sitem-insel AG

M4 - Regulatory Affairs

Module leaders: Dr. Barbara Jentges, Phact
Sandra Soniec, Meditec-consulting

Date and Credits

Start: 08.09.2021

Duration: 9 Weeks


The role of the different regulatory authorities along the translational pathway and the product specific requirements are presented.

Learning objectives

  • Understanding of the legal framework
  • Understanding the elements relevant for the registration of biomedical products
  • Basic understanding of new and innovative regulatory processes
  • Strategic planning of regulatory activities

Learning content

  • Legal framework for drugs and medical devices
  • Regulation of drugs
  • Certification of medical devices and diagnostic tools
  • Regulation of particular medical products such as orphan drugs
  • Regulation of combination products
  • Pharmacovigilance and materiovigilance

Module leaders

Dr. Barbara Jentges, PhACT Gmbh
Dr. Sandra Soniec, meditec Consulting Gmbh


Various experts from industry (meditec Consulting,
PhACT), academia and public institutions (University
of Basel, WHO)